FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834701710
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
70-171
Catalog number
70-171
Device description
Periotome, Hatchet, Double-Ended, Round Handle
Published
2018-04-18
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
EMQHOE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMQHoe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780203834PrimaryGS10
H834701710SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178020383410381780203834

GMDN Terms#

Term, Definition table
TermDefinition
Periotome, reusableA hand-held dental instrument used during tooth extraction to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process). This procedure reduces the need for luxation of the tooth and minimizes mechanical trauma to the bone tissue. The device is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. 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
00840018661318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMQ2026-01-28
D928400512RD0CHISEL 7-10 D/E ROUND HANDLEW.H. Holden, Inc.EMQ2026-01-06
10889950133603Hu-FriedyHU-FRIEDY MFG. CO., LLCEMQ2025-12-19
00841336108738Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMQ2025-11-11
00841013116513American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
00841013116537American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
10889950023102Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950025526Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
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10889950033361Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
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10889950092764Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092849Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
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