FDA UDI
In Commercial Distribution
🇺🇸 United States
Spectrum, Inc.
DI: 00855495007368
·
Model: 982-03955-000
·
SPECTRUM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Spectrum, Inc.
- Primary DI
- 00855495007368
- Version / Model
- 982-03955-000
- Catalog Number
- GCS-6920
- Company Name
- SPECTRUM, INC.
- Labeler DUNS
- 080458964
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-21
- Public Version
- 5
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- 797e79f8-556a-45cc-8b6a-3cfa6a157c80
Device Description
Sterile Equipment Drape, AssistArm Surgical Drape, 7" X 96", Latex Free
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPZ | Container, frozen donor tissue storage | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10855495007365 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00855495007368 | GS1 | ||||
| Package | 20855495007362 | GS1 | Shipper | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(214)492-0506 ext. 3
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K934630 | 000 |