FDA.reportPublic FDA data

Distraction Screws Caspar type

Primary DI
00810607000293
Brand
Distraction Screws Caspar type
Company
ACRA-CUT INC
Model
800-502x
Catalog number
800-502x
Device description
Distraction Screws Caspar type Quantity 10 DI 810607000286
Published
2017-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810607000293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810607000293008106070002938106070002930810607000293

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, sterileA small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
9782632210info@acracut.com

Regulatory Flags#

DUNS number
612611459
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810607000224Distraction Screws Caspar type800-499800-4992017-05-01
00810607000231Distraction Screws Caspar type800-499x800-499x2017-05-01
00810607000248Distraction Screw Caspar type800-500800-5002017-05-01
00810607000255Distraction Screws Caspar type800-500x800-500x2017-05-01
00810607000262Distraction Screws Caspar type800-501800-5012017-05-01
00810607000279Distraction Screws Caspar type800-501x800-501x2017-05-01
00810607000286Distraction Screws Caspar type800-502800-5022017-05-01
00810607002006ACRA-CUT14/9mm SDR (SMARTdrill)200-5002016-09-23
00810607002211ACRA-CUT14/11mm CDM210-2212016-09-23
00810607002310ACRA-CUT11/7mm DG-II mini200-3312016-09-23
00810607002419ACRA-CUT14/11mm DGR-I200-2412016-09-23
00810607002433ACRA-CUT11/7mm DR-I mini200-2432016-09-23
00810607002518ACRA-CUT14/11mm DGR-II200-2512017-01-17
00810607002532ACRA-CUT11/7mm DGR-II Mini200-2532016-09-23
00810607002556ACRA-CUT13/9mm DGR-II200-2552017-01-17
00810607002716ACRA-CUT14/11mm DGR-O200-2712016-09-23
00810607002754ACRA-CUT13/9mm DGR-O200-2752016-09-23
00810607002839ACRA-CUT8/5mm DGR-OS mini Stereotactic200-2832016-09-23
00810607000019Disposable Cranial Perforator200-241 14/11mm200-241 DGR-I2017-05-01
00810607000026Disposable Cranial Perforator200-243 11/7 mm200-243 DGR -12017-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756402545DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402552DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402569DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402576DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402590DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402620DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402682DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402712DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402729DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402736DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402743DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402538DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-06-26
05060212051721Clamp Cover Red (Small) 50mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051738Clamp Cover White (Med) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051745Clamp Cover Blue (Large) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10653160385769MEDLINEMEDLINE INDUSTRIES, INC.KDC2025-01-29
10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
10653160383123MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383130MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383147MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21