FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780203810
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
70-152
Catalog number
70-152
Device description
Knife, Orban 1-2, Double-Ended, Round Handle
Published
2018-04-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMOKNIFE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMOKnife, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780203810PrimaryGS10
H834701520SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178020381010381780203810

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791021260DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMO2026-08-15
G8791061250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMO2026-08-15
G879106127H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMO2026-08-15
G879106128H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMO2026-08-15
G879106129H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMO2026-08-15
00840018674011Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-11
00840018666009Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-09
00840018663367Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-04
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLEW.H. Holden, Inc.EMO2026-01-14
D9284001040D9284001040W.H. Holden, Inc.EMO2026-01-14
00841013121050Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121067Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121074Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121128Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121135Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121142Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121159Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
D9284005451HF0VESTIBULAR TUNNELING ELEVATOR #1 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005452HF0VESTIBULAR TUNNELING ELEVATOR #2 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005453HF0VESTIBULAR TUNNELING ELEVATOR #3 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005454HF0VESTIBULAR TUNNELING ELEVATOR #4 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005455HF0VESTIBULAR TUNNELING ELEVATOR #5 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005456HF0VESTIBULAR TUNNELING ELEVATOR #6 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
00840105223757ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223764ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223771ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223788ZOLL DENTALZoll-DentalEMO2025-08-06