FDA UDI In Commercial Distribution 🇺🇸 United States

Ambler Surgical

DI: 00190660216795 · Model: Lieberman comfort lid speculum · AMBLER SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ambler Surgical
Primary DI
00190660216795
Version / Model
Lieberman comfort lid speculum
Catalog Number
8033E
Company Name
AMBLER SURGICAL CORP.
Labeler DUNS
015272206
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-01-04
Public Version
1
Public Version Date
2021-01-12
Public Version Status
New
Public Device Record Key
8b152242-aaaa-4d7a-835e-33721b717c89

Device Description

Lieberman comfort lid speculum, 3 1/8'', adult size, 16.0mm open rounded wire blades, nasal approach, adjustable thumb-screw tension

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 00190660216795

Customer Contacts

Phone
+1(888)407-0006 ext. 0