FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780508137
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
PM-961
Catalog number
PM-961
Device description
Integra® Miltex® Hand Fixation Device, With Adjustable Finger and Wrist Restraints
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780508137PrimaryGS10
H834PM9610SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050813710381780508137

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. 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
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
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07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
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G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
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G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
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G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
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10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22