AccessGUDID - DEVICE: LLD™ #2 (00813132020767)

GUDID

Device Identifier (DI) Information

Brand Name: LLD™ #2
Version or Model: 518-019AA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 518-019
Company Name: Spectranetics Corporation

Primary DI Number: 00813132020767
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: Lead Locking Device (LLD™ #2)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47046	Pacing/defibrillation lead stylet, extraction	A sterile device designed to remove from the body the electrically-conducting leads (hollow coil type) of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter, and a working length of 70 cm). It is inserted into the central lumen of the cardiac lead where its locking mechanism is activated to attach it to the lead, whereupon the lead can be pulled free (extracted). It may also be used to extract an indwelling catheter or other foreign object. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRB	Stylet, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043401	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 140 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f0ace895-3757-4619-adc6-46847cff019b
Public Version Date: October 26, 2021
Public Version Number: 4
DI Record Publish Date: February 06, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20813132020761	3	00813132020767		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	M204518019AA0

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-633-0962
Email: complaints@spnc.com

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