FDA.reportPublic FDA data

Gelfilm

Primary DI
00300090297039
Brand
Gelfilm
Company
PFIZER INC.
Model
Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6
Device description
Anti-adhesion dressing, bioabsorbable
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQXIMPLANT, ORBITAL, EXTRA-OCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQXImplant, Orbital, Extra-OcularOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00300090297039PackageGS16In Commercial Distribution
00300090297015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00300090297039003000902970393000902970390300090297039
00300090297015003000902970153000902970150300090297015

GMDN Terms#

Term, Definition table
TermDefinition
Surgical anti-adhesion dressing, implantable, bioabsorbableA bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue to another following a surgical procedure. The device is typically implanted during abdominal or pelvic surgery to reduce the incidence of adhesions between adjacent anatomical structures. It is typically made of a modified cellulose material.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length50Millimeter
Width25Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00See USP Controlled Room Temperature
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(484)865-6166karena.arroyo@pfizer.com
+1(484)865-6166UDICompliance@pfizer.com

Regulatory Flags#

DUNS number
829076566
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415062388310wtATTR-CM AcceleraTTR™CI40542792022-07-29
00305733010020ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010037ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010075ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010389ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010396ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010969ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010983ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733013014ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733013038ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733013144ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733015025ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015353ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015445ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015957ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015971ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733017241ThermaCare HeatWrapsThermaCare HeatWraps - Flexible2020-05-29
00305733017258ThermaCare HeatWrapsThermaCare HeatWraps - Flexible2020-05-29
00305733020029ThermaCare HeatWrapsThermaCare HeatWraps - Menstrual2020-05-29
00305733020449ThermaCare HeatWrapsThermaCare HeatWraps - Menstrual2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760087121971HALF-SPONGE 2.75 X 7.5 TYPE 511FCI S A S FCI 20 22HQX2021-05-30
33760087121972HALF-SPONGE 2.75 X 7.5 TYPE 511FCI S A S FCI 20 22HQX2021-05-30
08717872014487Scleral Buckling Product Style 106, Meridional Implant - 10.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
08717872014555Scleral Buckling Product Style 505T, 5.0mm Round Tunel SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
08717872014661Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014484Scleral Buckling Product Style 106, Meridional Implant - 10.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014552Scleral Buckling Product Style 505T, 5.0mm Round Tunel SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014668Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
03760087121179Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121186Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121193Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121216Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121230Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121247Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121254Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121292Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121308Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121391Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121421Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121438Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121452Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121520Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121537Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121544Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121551Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121803Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121810Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121827Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121872Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121896Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06