FDA UDI
In Commercial Distribution
🇺🇸 United States
E5107N Cover, Back Table, 150x240cm PSB (Absorbent Reinforcement) -60x240cm
DI: 00816953021005
·
Model: E5107N
·
EXACT MEDICAL MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- E5107N Cover, Back Table, 150x240cm PSB (Absorbent Reinforcement) -60x240cm
- Primary DI
- 00816953021005
- Version / Model
- E5107N
- Catalog Number
- E5107N
- Company Name
- EXACT MEDICAL MANUFACTURING, INC.
- Labeler DUNS
- 014464314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 5
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- ffd9dcf7-9570-47bc-9e30-a157c9d1a8ea
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYA | Gown, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35091 | Surgical gown, single-use | A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00816953021012 | GS1 | Case | 360 | In Commercial Distribution | |
| Primary | 00816953021005 | GS1 |
Customer Contacts
- Phone
- 716-681-0866
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101598 | 000 |