FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834PM5500
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
PM-550
Catalog number
PM-550
Device description
Pollock-Dingman Septum Displacer 8", Serrated
Published
2018-04-03
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
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780460817PrimaryGS10
H834PM5500SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178046081710381780460817

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. 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
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
B35675400020American MedicalsAmerican MedicalsGAC2026-05-20
05055445940881SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940898SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940904SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940911SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940928SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973001SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973018SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973025SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973032SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
00190776421014MillenniumAvalign Technologies, Inc.GAC2026-04-30
B356ED469970American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470040American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470050American MedicalsAmerican MedicalsGAC2026-04-07
B356FF114000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115020American MedicalsAmerican MedicalsGAC2025-05-27
10888277374324MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10888277382992MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10080196382989MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10080196384983MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277374515MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377004MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377011MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377509MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277381971MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277382442MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384286MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384415MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277385863MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29