FDA UDI In Commercial Distribution 🇺🇸 United States

QUICKANCHOR PANACRYL

DI: 10886705001958 · Model: 212131 · DEPUY MITEK, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
QUICKANCHOR PANACRYL
Primary DI
10886705001958
Version / Model
212131
Catalog Number
212131
Company Name
DEPUY MITEK, LLC
Labeler DUNS
190572854
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-01
Public Version
4
Public Version Date
2019-03-21
Public Version Status
Update
Public Device Record Key
f11cbd1e-02cc-4151-98c1-c5e94c79f3b6

Device Description

Rotator Cuff QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), with CP-2 needles, with disposable inserter

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 Conditional
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
HWC Screw, fixation, bone

GMDN Terms

Code Name
45062 Tendon/ligament bone anchor, non-bioabsorbable

Identifiers

Type ID
Primary 10886705001958

Customer Contacts

Storage Conditions

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