FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H8345D3290
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
5D-329
Catalog number
5D-329
Device description
Locklin Scissors, 6-1/4", Curved Shanks, Angled on Side, One Serrated Blade
Published
2018-10-24
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
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780495178PrimaryGS10
H8345D3290SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178049517810381780495178

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00841013124716MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.EGN2026-06-26
B382S37841020Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37842000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37935000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903070100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903071100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD90315118T0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9034541060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035521000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035651000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037861000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037871010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903797030Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903870060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039790010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039871000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
04059453162762Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEGN2026-05-29
G149NPGFS0NPSACME ENTERPRISE.EGN2026-05-01
08961104625839MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625846MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625853MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625860MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625877MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625884MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625891MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625907MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625914MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625921MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625938MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625945MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22