FDA UDI In Commercial Distribution 🇺🇸 United States

L-557B

DI: 00841336100459 · Model: L-557B · Salvin Dental Specialties, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
L-557B
Primary DI
00841336100459
Version / Model
L-557B
Company Name
Salvin Dental Specialties, Inc.
Labeler DUNS
113344790
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-02-22
Public Version
4
Public Version Date
2023-12-18
Public Version Status
Update
Public Device Record Key
15cd73a6-cd4c-46e7-ae4b-83387889df6e

Device Description

SALVIN 5-0 CHROMIC GUT FS-2 NEEDLE 27" (70CM)

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
45025 Catgut suture, chromic

Identifiers

Type ID
Primary 00841336100459

Premarket Submissions

Submission Number Supplement Number
K896554 000