FDA UDI In Commercial Distribution 🇺🇸 United States

Huntsville GYN ROBOTIC PACK

DI: 00817395022629 · Model: HH210 · PACKROOM LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Huntsville GYN ROBOTIC PACK
Primary DI
00817395022629
Version / Model
HH210
Company Name
PACKROOM LLC
Labeler DUNS
015179820
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-11-10
Public Version
1
Public Version Date
2021-11-18
Public Version Status
New
Public Device Record Key
3a861595-5d87-417e-a039-68a3784b1bf8

Device Description

Huntsville GYN ROBOTIC PACK

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

GMDN Terms

Code Name
60644 Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary 00817395022629