AccessGUDID - DEVICE: SEPRAFILM (05413765589621)

GUDID

Device Identifier (DI) Information

Brand Name: SEPRAFILM
Version or Model: 664201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 664201
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 05413765589621
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34212	Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated	A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MCN	Barrier, absorbable, adhesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950034	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Inch
Width: 5 Inch

Device Record Status

Public Device Record Key: 42aa024b-d8fc-47cf-8d42-37d41c994ad3
Public Version Date: July 19, 2023
Public Version Number: 4
DI Record Publish Date: June 10, 2021