FDA.reportPublic FDA data

Kirwan

Primary DI
10841019107703
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
40-1001
Device description
Cranio - Blade Sterile Disposable
Published
2016-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861876000CRANIO BLADES AND WIRE PASS DRILLNew England Surgical Instrument Corp.1986-05-30GFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019107703PackageGS15In Commercial Distribution
00841019107706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101910770310841019107703
00841019107706008410191077068410191077060841019107706

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bur, single-useA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-834-9500kprario@ksp.com

Regulatory Flags#

DUNS number
046355210
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841019123836Kirwan20-1417NSS2026-05-13
00841019123881Kirwan14-90202026-05-01
00841019123812Kirwan10-2202NSS2026-04-14
00841019123829Kirwan10-2202NSS2026-04-14
00841019123799Kirwan12-1633AUS2026-02-20
00841019123706Kirwan10-3442AUS2026-02-11
00841019123676Kirwan20-1620AUS2026-02-07
00841019123683Kirwan10-5603AUS2026-01-31
00841019123690Kirwan10-5603AUS2026-01-31
00841019123669Kirwan12-1432AUS2026-01-29
00841019123614Kirwan10-1403AUS2025-12-24
00841019123645Kirwan10-5602NSS2025-11-21
00841019123638Kirwan12-1434EAUS2025-11-19
00841019123621Kirwan20-1413EAUS2025-11-14
00841019123652Kirwan21-1411AUS2025-11-05
00841019123560Kirwan10-1603AUS2025-10-31
00841019123591Kirwan20-1618AUS2025-10-31
00841019123553Kirwan20-1613AUS2025-10-28
00841019123577Kirwan20-1621AUS2025-10-28
00841019123546Kirwan12-1400AUS2025-10-11

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