FDA.reportPublic FDA data

RULTRACT

Primary DI
B152410052D0
Brand
RULTRACT
Company
PEMCO INC
Model
4100-52D
Catalog number
4100-52D
Device description
Rultract Sternal Rake Plate Assembly, Dull Tip
Published
2021-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B152410052D0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-550-5695philip@rultract.com

Regulatory Flags#

DUNS number
004217071
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B152410028CS020RULTRACT4100-28CS-024100-28CS-022025-11-21
B152410032AS020RULTRACT4100-32AS-024100-32AS-022025-11-21
B1524150S020RULTRACT4150S-024150S-022025-11-21
B1524160S020RULTRACT4160S-024160S-022025-11-21
B152410028CS010RULTRACT4100-28CS-014100-28CS-012024-03-11
B152410032AS010RULTRACT4100-32AS-014100-32AS-012024-03-11
B1524150S010RULTRACT4150S-014150S-012024-03-11
B1524160S010RULTRACT4160S-014160S-012024-03-11
B1524100080RULTRACT4100-084100-082021-12-06
B152410012R0RULTRACT4100-12R4100-12R2021-12-06
B152410012RD0RULTRACT4100-12RD4100-12RD2021-12-06
B152410020NE0RULTRACT4100-20NE4100-20NE2021-12-06
B152410020P0RULTRACT4100-20P4100-20P2021-12-06
B152410020SP0RULTRACT4100-20SP4100-20SP2021-12-06
B152410028C0RULTRACT4100-28C4100-28C2021-12-06
B152410028CP0RULTRACT4100-28CP4100-28CP2021-12-06
B152410028CS0RULTRACT4100-28CS4100-28CS2021-12-06
B152410032A0RULTRACT4100-32A4100-32A2021-12-06
B152410032AL0RULTRACT4100-32AL4100-32AL2021-12-06
B152410032ALS0RULTRACT4100-32ALS4100-32ALS2021-12-06

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