FDA.report

SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

Primary DI
07540194008336
Brand
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
Company
Pega Medical Inc
Model
SLM-DCA048
Catalog number
SLM-DCA048
Device description
SLIM REAMER Ø4.8mm
Published
2020-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540194008336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540194008336075401940083367540194008336

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes

TypeValueUnit
Length330Millimeter
Lumen/Inner Diameter2.2Millimeter
Outer Diameter4.8Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(450)688-5144egarcia@pegamedical.com

Regulatory Flags

DUNS number
257315713
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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07540194012074SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-28PEG-CFL-282024-09-11
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07540194015921GIRO GROWTH MODULATION SYSTEMGRO-CYF150-45GRO-CYF150-452024-09-11
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