FDA.reportPublic FDA data

Gelfilm

Primary DI
10300090283015
Brand
Gelfilm
Company
PHARMACIA & UPJOHN COMPANY LLC
Model
Gelfilm® Sterile Film Sterile film 1's (125 sq cm)
Device description
Anti-adhesion dressing, bioabsorbable
Published
2016-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
10300090283015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030009028301510300090283015

GMDN Terms#

Term, Definition table
TermDefinition
Surgical anti-adhesion material, 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 in the form of a barrier membrane or fluid dressing.

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)865-6166UDICompliance@pfizer.com

Regulatory Flags#

DUNS number
618054084
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10300132647034Genotropin Pen® 12F0000991112019-09-05
10300134761929Genotropin Pen® 5F0001161532019-09-05
00300090297015GelfilmGelfilm® Sterile Ophthalmic Film Ophthalmic film 62015-10-22
00300090283018GelfilmGelfilm® Sterile Film Sterile film 1's (125 sq cm)2015-10-22
00300091040016GEL-FLOW™ NTHemostatic Matrix for Flowable Applications - 6 mL2018-04-17
00300092250018GEL-FLOW KIT6 mL2018-08-17
00360793310107GELFOAM-JMI™ Sponge KitSize 1002017-06-05
00360793410104GELFOAM-JMI™ Powder Kit1 g Powder2017-06-05
10300090315082GelfoamSize 12-72014-09-01
10300090323018GelfoamSize 502014-09-01
10300090342019GelfoamSize 1002014-09-01
10300090349032GelfoamSize 2002014-09-01
10300090353015GelfoamSize 100 - Compressed2014-09-01
10300090396050GelfoamSize 4, 2 sponges per envelope2014-09-01
10300090433045Gelfoam1 g Powder2014-09-01
00300093359017Prepidil® Gel, dinoprostone cervical gelNDC 0009-3359-012020-09-24
00300090315085GelfoamSize 12-72014-09-01
00300090323011GelfoamSize 502014-09-01
00300090342012GelfoamSize 1002014-09-01
00300090349035GelfoamSize 2002014-09-01

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Primary DI, Brand, Company table
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