FDA.report

Surgical Direct

Primary DI
B382SD904201710
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD90420171
Catalog number
SD90420171
Device description
8 inch Fomon Bone Rasp, Size 3 & 4, TC
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SD904201710PrimaryHIBCC0

GMDN Terms

TermDefinition
Callous file/rasp, reusableA hand-held manual instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to be rubbed back and forth over the skin to remove callouses (i.e., hardened and thickened protrusions of skin commonly known as hard skin). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags

DUNS number
124367223
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 DIBrandModelCatalogPublished
B382S1350010Surgical DirectS1350.01S1350.012026-03-09
B382S18382020Surgical DirectS1838.202S1838.2022026-03-09
B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
B382S18382050Surgical DirectS1838.205S1838.2052026-03-09
B382S18382060Surgical DirectS1838.206S1838.2062026-03-09
B382S18382100Surgical DirectS1838.210S1838.2102026-03-09
B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
B382S2511200Surgical DirectS2511.20S2511.202026-03-09
B382S2548010Surgical DirectS2548.01S2548.012026-03-09
B382S2548020Surgical DirectS2548.02S2548.022026-03-09
B382S2871200Surgical DirectS2871.20S2871.202026-03-09
B382S344901020Surgical DirectS34490.102S34490.1022026-03-09
B382S3797050Surgical DirectS3797.05S3797.052026-03-09
B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

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