FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H8347610
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
76-1
Catalog number
76-1
Device description
Articulating Paper Forceps 6", PosiGrip
Published
2018-01-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFKFORCEPS, ARTICULATION PAPER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFKForceps, Articulation PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780438397PrimaryGS10
H8347610SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178043839710381780438397

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paper forcepsA hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4290TBS BASICSACME ENTERPRISE.EFK2026-05-21
00889813066553Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFK2024-11-30
00813677022486PDT, Inc.PDT, INC.EFK2024-07-01
00842517103924Karl SchumacherKarl Schumacher Dental, LLCEFK2024-02-27
08800075603579OSUNG MNDOSUNG MND Co., Ltd.EFK2024-02-19
08964003163488NivoB. Ali ImpexEFK2024-01-29
08964003163662PREHMAB. Ali ImpexEFK2024-01-29
00310866002590NANOBYTEPASCAL COMPANY, INC.EFK2023-11-29
D040603000Forceps- PaperWHIP-MIX CORPORATIONEFK2023-08-18
07898506812141QuinelatoSchobell Industrial LtdaEFK2022-12-08
00887919408963Brasseler USAPeter Brasseler Holdings, LLCEFK2022-12-08
EZPF22100150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
EZPF22101150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
04963931270668NAYDM CORPORATIONEFK2022-09-30
04963931270675NAYDM CORPORATIONEFK2022-09-30
D77370010500Health-Tec/DHP Hand InstrumentsDental Health Products IncEFK2022-09-28
00850043381174Buffalo Dental MfgBuffalo Dental Manufacturing Co., Inc.EFK2022-08-05
00366975051059BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
00366975051066BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
G1577083000PomeePOMEE CORPORATIONEFK2022-01-04
G1577083050PomeePOMEE CORPORATIONEFK2022-01-04
G1577083100PomeePOMEE CORPORATIONEFK2022-01-04
D701ARPH2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D701ARPS2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D72310296083Safco Articulating Paper ForcepsSAFCO DENTAL SUPPLY CO.EFK2021-07-01
00840105217466ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217473ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217503ZOLL-DENTALZoll-DentalEFK2021-03-10
10889950004323HU-FRIEDYHU-FRIEDY MFG. CO., LLCEFK2020-11-12
10889950041489HU-FRIEDYHU-FRIEDY MFG. CO., LLCEFK2020-11-12