FDA.report

TEE Kit

Primary DI
00841436108331
Brand
TEE Kit
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
811-053
Catalog number
811-053
Device description
Table Adapter, TEE Transducer Holder, CIV-Flex™ Transducer Covers (12)
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841436108331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436108331008414361083318414361083310841436108331

GMDN Terms

TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Device Sizes

TypeValueUnit
Height4.5Inch
Length5.2Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(319)248-6502regulatory@civco.com

Regulatory Flags

DUNS number
134614411
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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