FDA UDI In Commercial Distribution 🇺🇸 United States

KIM (Knotless Incontinence Mesh)

DI: 08437007606683 · Model: KIM-01 · DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
KIM (Knotless Incontinence Mesh)
Primary DI
08437007606683
Version / Model
KIM-01
Company Name
DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Labeler DUNS
513271056
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-19
Public Version
2
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
c185bb9e-5077-41ad-a53d-4e3066f5699d

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
Yes
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
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

GMDN Terms

Code Name
47986 Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Identifiers

Type ID
Primary 08437007606683