FDA UDI
In Commercial Distribution
🇺🇸 United States
Coulmed
DI: 10810087352117
·
Model: AC1406-C02
·
Coulmed Products Group LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Coulmed
- Primary DI
- 10810087352117
- Version / Model
- AC1406-C02
- Catalog Number
- AC1406-C02
- Company Name
- Coulmed Products Group LLC
- Labeler DUNS
- 047115479
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-06
- Public Version
- 1
- Public Version Date
- 2023-01-16
- Public Version Status
- New
- Public Device Record Key
- d2515d47-9c02-4eb2-b077-c904eb043b4b
Device Description
Two Tier Instrument Table with Adjustable/Removable Angled Top Tier. Solid 16-gauge 304 Stainless Steel Welded Construction. No Open Cavities for Unwanted Substances. Overall Dimensions: 72" wide x 30" deep x 44" to 48" high. Top Tier: 72" wide x 20" deep
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FSM | TRAY, SURGICAL, INSTRUMENT | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13959 | Instrument table | A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810087352117 | GS1 |