FDA UDI
In Commercial Distribution
🇺🇸 United States
UltimaBloc Endoscopy Bite Block
DI: 00893029002557
·
Model: GIS-4
·
GI Supply, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- UltimaBloc Endoscopy Bite Block
- Primary DI
- 00893029002557
- Version / Model
- GIS-4
- Catalog Number
- GIS-4-G
- Company Name
- GI Supply, Inc.
- Labeler DUNS
- 160990313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-07
- Public Version
- 1
- Public Version Date
- 2021-07-15
- Public Version Status
- New
- Public Device Record Key
- bcdacc1b-e682-4f76-97ff-ed4c5013f3e0
Device Description
Endoscopy Bite Block
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
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNK | Endoscopic Bite Block | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34143 | Endoscopic bite block, basic, single-use | A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10893029002554 | GS1 | Master | 100 | In Commercial Distribution | |
| Primary | 00893029002557 | GS1 | ||||
| Package | 20893029002551 | GS1 | Dispenser | 25 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K931044 | 000 |