FDA UDI In Commercial Distribution 🇺🇸 United States

TEE Kit

DI: 00841436108331 · Model: 811-053 · CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TEE Kit
Primary DI
00841436108331
Version / Model
811-053
Catalog Number
811-053
Company Name
CIVCO MEDICAL INSTRUMENTS CO., INC.
Labeler DUNS
134614411
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-22
Public Version
3
Public Version Date
2021-09-06
Public Version Status
Update
Public Device Record Key
9c0e7d55-20cf-42d6-b962-fba28ae6f650

Device Description

Table Adapter, TEE Transducer Holder, CIV-Flex™ Transducer Covers (12)

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GDJ CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

GMDN Terms

Code Name
32288 Surgical camera holder

Identifiers

Type ID
Primary 00841436108331

Customer Contacts

Device Sizes

Type Value Unit Text
Height 4.5 Inch
Length 5.2 Inch

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Keep Away from Sunlight
Type
Storage Environment Temperature
Temperature Range
52 – 85 Degrees Fahrenheit