FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834183721
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
18-372
Device description
Davis Foreign Body Spud 4-3/4", 0.8mm blade
Published
2017-06-28
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
HNASpud, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780363057PrimaryGS10
H834183721SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036305710381780363057

GMDN Terms#

Term, Definition table
TermDefinition
Eye spud/needleA hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. 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

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04251047928604Drysdale Nucleus ManipulatorA1 Medical GmbHHNA2026-06-09
05056111322123SurtexSURTEX INSTRUMENTS LTD.HNA2026-05-12
00041533986539Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00041533996538Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
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00887482108628Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HNA2024-08-20
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