FDA UDI In Commercial Distribution 🇺🇸 United States

L-591B

DI: 00841336100602 · Model: L-591B · Salvin Dental Specialties, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
L-591B
Primary DI
00841336100602
Version / Model
L-591B
Company Name
Salvin Dental Specialties, Inc.
Labeler DUNS
113344790
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-30
Public Version
4
Public Version Date
2023-12-18
Public Version Status
Update
Public Device Record Key
10e5717f-8eec-4404-b51b-d99d46ef328c

Device Description

SALVIN 4-0 GUT PLAIN C6(FS-2) NEEDLE 18" (45CM)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
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
GAL Suture, Absorbable, Natural

GMDN Terms

Code Name
13898 Catgut suture, plain

Identifiers

Type ID
Package 10841336100609
Primary 00841336100602

Premarket Submissions

Submission Number Supplement Number
K896554 000