FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834ST8441
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
ST8-44
Catalog number
ST8-44
Device description
Mayo-Hegar Needle Holders, 6-1/4", Sterile, Box of 50
Published
2018-10-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780470953PrimaryGS10
H834ST8441SecondaryHIBCC0
00381780470956Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178047095310381780470953
00381780470956003817804709563817804709560381780470956

GMDN Terms#

Term, Definition table
TermDefinition
Needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not use if package is damaged

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800195Adler Instrument CompanyAdler, Inc.FHQ2026-05-26
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G453230117BCR0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
04059453049339Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-03-10
B382SD9056641000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
B382SD9056791000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
00192896106833Matthieu Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-02-26
B382SD905662170Surgical DirectSurgical Direct, Inc.FHQ2026-02-20
G4254202130My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202200My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202240My MedicalMy Medical Store LLCFHQ2026-02-17
B382SD905434160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD90548817LH0Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9055891110Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9056791160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9084551100Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
00192896122628Glasser Micro Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00192896122673Derf Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00848657076012AED 6250 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Left JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
D928301140LH0NEEDLE HOLDER MAYO-HEGAR 7" LEFT HAND TCW.H. Holden, Inc.FHQ2026-01-05
D9283011450NEEDLE HOLDER MAYO-HEGAR 8" / 20CM TCW.H. Holden, Inc.FHQ2026-01-05
D9283011510NEEDLE HOLDER OLSEN-HEGAR 4 1/2" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011570NEEDLE HOLDER OLSEN-HEGAR 7 1/4" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011600NEEDLE HOLDER RYDER 5 1/8" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011640NEEDLE HOLDER FRENCH RYDER 9" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011650NEEDLE HOLDER HEANEY 8 1/4" - 20CMW.H. Holden, Inc.FHQ2026-01-05
D928301173OS0NEEDLE HOLDER MINI-RYDER 6" SM OFF SET HANDLEW.H. Holden, Inc.FHQ2026-01-05
D92830117470NEEDLE HOLDER MINI-RYDER 7" TC NEW PATTERNW.H. Holden, Inc.FHQ2026-01-05
D928301174D0NEEDLE HOLDER MINI-RYDER 7" DELICATE, TC SERRATEDW.H. Holden, Inc.FHQ2026-01-05