FDA UDI In Commercial Distribution 🇺🇸 United States

Bausch + Lomb

DI: 00757770636891 · Model: SP7-70641 · Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Bausch + Lomb
Primary DI
00757770636891
Version / Model
SP7-70641
Catalog Number
SP7-70641
Company Name
Bausch & Lomb Incorporated
Labeler DUNS
196603781
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-08-05
Public Version
1
Public Version Date
2025-08-13
Public Version Status
New
Public Device Record Key
0e012b0e-ca35-4c28-b4a8-1838705484f3

Device Description

E4065 A SPEC W/10MM WIRE BLDS

Device Characteristics

Single Use
No
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HNC Specula, Ophthalmic

GMDN Terms

Code Name
35349 Eyelid speculum, reusable

Identifiers

Type ID
Primary 00757770636891