FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950020705
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
PTRTCL
Catalog number
PTRTCL
Device description
Silicone Tube - 4 ft long
Published
2020-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBNGAG, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950020705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995002070510889950020705

GMDN Terms#

Term, Definition table
TermDefinition
Clamp jaw covers, non-sterileA non-sterile device used in pairs that are placed/fitted onto the distal working end (the jaws) of surgical instruments (e.g., vascular clamps, haemostats and forceps) to provide improved atraumatic grip and even pressure distribution when clamping an artery or a vein. It is typically a long device designed as a cylindrical tube and made of radiopaque silicone materials; it is available in various sizes. Sterilization takes place along with the instrument prior to the procedure. It may also be known as jaw covers. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800012410970Hu-FriedySSC-ULD22024-10-14
08800012410987Hu-FriedySSC-ULD32024-10-14
08800012410994Hu-FriedySSC-ULD42024-10-14
08800012411014Hu-FriedySSC-ULD62024-10-14
08800012411021Hu-FriedySSC-ULD72024-10-14
08800012411045Hu-FriedySSC-URD32024-10-14
08800012411052Hu-FriedySSC-URD42024-10-14
08800012411069Hu-FriedySSC-URD52024-10-14
08800012411076Hu-FriedySSC-URD62024-10-14
08800012411083Hu-FriedySSC-URD72024-10-14
08800012411090Hu-FriedySSC-LLD22024-10-14
08800012411106Hu-FriedySSC-LLD32024-10-14
08800012411113Hu-FriedySSC-LLD42024-10-14
08800012411120Hu-FriedySSC-LLD52024-10-14
08800012411137Hu-FriedySSC-LLD62024-10-14
08800012411144Hu-FriedySSC-LLD72024-10-14
08800012411151Hu-FriedySSC-LRD22024-10-14
08800012411168Hu-FriedySSC-LRD32024-10-14
08800012411175Hu-FriedySSC-LRD42024-10-14
08800012411274Hu-FriedySSC-URE22024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141548140010Carnegie Surgical LLCCarnegie Surgical LLCKBN2026-10-08
G141548140020Carnegie Surgical LLCCarnegie Surgical LLCKBN2026-10-07
G141548131100Carnegie Surgical LLCCarnegie Surgical LLCKBN2026-09-30
G8791062340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
G8791062360DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
G8791062380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
00190776405755MillenniumAvalign Technologies, Inc.KBN2026-07-24
14026704810069PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810076PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810083PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
ESAM4011541STOMA®Storz am Mark GmbHKBN2022-11-07
ESAM3725121STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740111STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740141STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033001STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033011STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033021STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033031STOMA®Storz am Mark GmbHKBN2020-08-27
10889950015695Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015701Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015718Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10381780448822Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-10-23
14026704630742PILLINGTELEFLEX INCORPORATEDKBN2018-10-22
10381780506485Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780507857Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780487807Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-29
10381780487814Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487821Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487845Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780437963Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-16