FDA.reportPublic FDA data

Gelfilm

Primary DI
00363539020018
Brand
Gelfilm
Company
PFIZER INC.
Model
Gelfilm® Sterile Film Sterile film 1's (125 sq cm)
Device description
Anti-adhesion dressing, bioabsorbable
Published
2015-10-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OODsurgical film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OODSurgical FilmGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00363539020018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00363539020018003635390200183635390200180363539020018

GMDN Terms#

Term, Definition table
TermDefinition
Anti-adhesion dressing, bioabsorbableA sterile 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
Length125Millimeter
Width100Millimeter

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

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

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