FDA.reportPublic FDA data

Director Biopsy/Needle Guide/PullUp Probe Cover Kits

Primary DI
00841912103263
Brand
Director Biopsy/Needle Guide/PullUp Probe Cover Kits
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
7220
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841912103263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841912103263008419121032638419121032630841912103263

GMDN Terms#

Term, Definition table
TermDefinition
Body-surface ultrasound imaging transducer coverA device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965417181
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841912106049System Cover107410742020-11-06
10841912106490Sterile Protective Barrier Kit162416242020-06-01
10841912106506Sterile Protective Barrier Kit162816282020-06-01
10841912106513Sterile Protective Barrier Kit164816482020-06-01
10841912106520Sterile Protective Barrier Kit169616962020-06-01
00841912106691Reusable Biopsy Bracket62772020-11-13
00841912106745Biopsy Starter Kit72772020-11-13
10841912107107Sterile Disposable Endocavity Needle Guide545554552022-04-01
10841912107084Sterile Single-Use Probe Cover Kit264826482022-03-11
10841912107091Sterile Single-Use Surgical Probe Cover Kit269626962022-03-11
00841912107049Reusable Biopsy Bracket62962021-12-17
10841912107053General Purpose Probe Cover2323VPC55362021-12-17
00841912107070Biopsy Starter Kit72962021-12-17
00841912107018Biopsy Starter Kit72932021-10-22
00841912107032Multi-Angle Biopsy Starter Kit72942021-10-22
00841912106783Reusable Biopsy Bracket63062021-10-08
00841912106998Multi-Angle Biopsy Starter Kit73062021-10-08
00841912106981Multi Angle Biopsy Starter Kit73632021-09-30
20841912104714Probe Storage Covers11402021-09-20
10841912106971PullUp Sterile Single-Use Surgical Probe Cover Kit208720872021-07-30