FDA UDI In Commercial Distribution 🇺🇸 United States

GRYPHON PROKNOT PERMACORD

DI: 10886705024025 · Model: 210820 · Medos International Sàrl
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GRYPHON PROKNOT PERMACORD
Primary DI
10886705024025
Version / Model
210820
Catalog Number
210820
Company Name
Medos International Sàrl
Labeler DUNS
482661753
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-01
Public Version
5
Public Version Date
2023-12-22
Public Version Status
Update
Public Device Record Key
0ee5ddd0-ad11-416c-ac97-d28aaf3f83f5

Device Description

GRYPHON BR Anchor w/PROKNOT Technology TCP/PLGA Absorbable Anchor (1) Number 1 PERMACORD Suture w/PROKNOT Technology

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MBI FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
MAI FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

GMDN Terms

Code Name
45061 Tendon/ligament bone anchor, bioabsorbable

Identifiers

Type ID
Primary 10886705024025

Customer Contacts

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
High: 77 Degrees Fahrenheit
Type
Storage Environment Temperature
Temperature Range
High: 25 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
High: 77 Degrees Fahrenheit
Type
Handling Environment Temperature
Temperature Range
High: 25 Degrees Celsius